FDA.reportPublic FDA data

Pyrimethamine

Product NDC
0480-3720
11-digit product format
004803720
Labeler code
0480
Product ID
0480-3720_90ea4054-7c0a-4971-be57-d72e482491b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pyrimethamine
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA215506
Marketing category
ANDA
Marketing start
2021-12-15
Substance
PYRIMETHAMINE
Active strength
25 mg/1
Pharmacologic classes
Dihydrofolate Reductase Inhibitor Antimalarial [EPC], Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pyrimethamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRIMETHAMINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ3614QOX8W
Rxcui198182

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
927bc290-af6b-41d8-9ce2-cbb0b8d5cf88Product name320240102
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0480-3720-01Pyrimethamine100 in 1 BOTTLE, PLASTICTABLET1002
0480-3720-56Pyrimethamine30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-3720-01EA - Each0480-37208d25346c-f3a7-4453-876e-0a76522f33cd12022-01-06
0480-3720-56EA - Each0480-3720b722b860-1d7f-495f-ba9f-6f9438be6a2e12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-3720PYRIMETHAMINE TABLET [TEVA PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20211216_2c57a992-619b-40ce-9395-f12ac47a2c67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198182pyrimethamine 25 MG Oral TabletPSN2c57a992-619b-40ce-9395-f12ac47a2c672
198182pyrimethamine 25 MG Oral TabletSCD2c57a992-619b-40ce-9395-f12ac47a2c672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0480-3720-0100480372001100 TABLET in 1 BOTTLE, PLASTIC (0480-3720-01) 100 tablet2021-12-150000-00-00NoNoCurrent
0480-3720-560048037205630 TABLET in 1 BOTTLE, PLASTIC (0480-3720-56) 30 tablet2021-12-150000-00-00NoNoCurrent